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Study of nivolumab plus drug combination versus standard first-line therapy in patients with advanced Hodgkin lymphoma

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on patients with advanced Hodgkin lymphoma, a type of cancer that starts in the cells of the lymphatic system. Two treatment plans are being compared. The first plan, called N‑AVD, combines the immune‑system drug nivolumab given by infusion with the chemotherapy medicines doxorubicin, vinblastine and dacarbazine. The second plan, known as BrECADD, uses the targeted therapy brentuximab vedotin, the chemotherapy agent etoposide, the steroid dexamethasone, and also includes dacarbazine and doxorubicin.

The purpose of the study is to demonstrate that the N‑AVD regimen is not worse than the BrECADD regimen in achieving a complete metabolic response, which is evaluated using PET/CT imaging about six to eight weeks after the chemotherapy is finished.

Participants receive the assigned drugs by infusion or injection every three weeks for a series of treatment cycles. After the final cycle, a PET/CT scan checks whether the cancer has disappeared. Follow‑up visits continue for several years to monitor overall survival, disease‑free time, quality of life, and any side effects, with occasional blood tests to look for disease markers and hormone recovery.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline assessment

    After enrollment, you will undergo initial evaluations including medical history, physical examination, and laboratory tests. these establish a reference point before treatment begins.

  2. Step 2

    First chemotherapy cycle

    You will receive the first cycle of the assigned treatment regimen. the regimen may be either the n-avd combination or the brecadd combination.

    For the n-avd regimen, the following medicines are given: nivolumab 240 mg by intravenous infusion, doxorubicin 25 mg/m2 by injection for infusion, vinblastine sulfate 6 mg/m2 intravenously, and dacarbazine 375 mg/m2 intravenously. each drug is administered on the day of the cycle as directed by the clinical team.

    For the brecadd regimen, the medicines include: brentuximab vedotin 180 mg intravenously, etoposide 150 mg/m2 intravenously, dexamethasone 40 mg taken orally, dacarbazine 250 mg/m2 intravenously, and doxorubicin 40 mg/m2 intravenously. each drug is given on the day of the cycle.

  3. Step 3

    Subsequent chemotherapy cycles

    Additional cycles are repeated in the same way as the first cycle. the number of cycles is decided by the treating physician and continues until the planned chemotherapy course is finished.

    After each cycle, you will be monitored for side effects and any adverse events according to standard criteria.

  4. Step 4

    Assessment after two cycles

    After completing two cycles, imaging (pet/ct) and blood tests for circulating tumor dna and tarc are performed to evaluate disease response.

    A quality of life questionnaire is also completed at this time.

  5. Step 5

    End of chemotherapy

    When the planned number of cycles is completed, a final imaging study (pet/ct) is performed 6–8 weeks later to determine the complete metabolic response.

    A second quality of life questionnaire is completed at the end of treatment.

    Blood tests for ctDNA and tarc are repeated at this point.

  6. Step 6

    Follow‑up visits

    Regular follow‑up visits are scheduled throughout the study period to monitor progression‑free survival, event‑free survival, and overall survival.

    At each visit, the quality of life questionnaire may be administered.

  7. Step 7

    Gonadal recovery assessment

    One year after chemotherapy ends, a blood test measuring follicle‑stimulating hormone is performed to assess gonadal recovery.

Who can join the trial?

9 criteria

  • Must meet all requirements of the National Health Fund Drug Program B.77 (points 1.1 and 1.2.2) – the patient must follow the basic rules set by the national health insurance program.
  • ECOG performance status 0–2 – this measures how well a person can carry out daily activities, where 0 means fully active and 2 means some limitation but still able to care for oneself.
  • Newly diagnosed classic Hodgkin lymphoma that tests positive for CD30 – the cancer must be confirmed by a tissue test and show the protein CD30, which is a marker used by doctors.
  • Advanced stage of disease – the cancer must be either:
    • Stage IIB with a large tumor (at least 10 cm or covering one‑third of the chest width) or spread to organs outside the lymph nodes, or
    • Stage III or IV, which means the disease has spread to multiple areas of the body, according to the Ann Arbor classification system (a way doctors describe how far cancer has spread).
    • Age 18 years or older – the patient must be an adult.
    • Written informed consent – the patient must sign a document showing they understand the study and agree to take part.
    • Women of childbearing potential – must have a negative pregnancy test before joining, and agree to use a highly effective birth‑control method during the study and for six months after the last treatment dose. Women are not considered of childbearing potential if they are post‑menopausal (no periods for at least 12 months without another medical cause) or permanently sterile (such as after removal of the uterus or ovaries).
    • Men of reproductive potential – must either use a condom during sex, ensure their partner uses a highly effective birth‑control method, or choose to abstain from sexual activity, both during the study and for six months after the last treatment dose.

Who cannot join the trial?

13 criteria

  • You must be 18 years of age or older; people younger than 18 cannot join.
  • You cannot have an active infection with HIV (the virus that causes AIDS), HBV (hepatitis B virus), HCV (hepatitis C virus), or CMV (cytomegalovirus).
  • You must not be known to have hypersensitivity (allergic reaction) to any of the medicines used in the study.
  • You need to be able to give written informed consent (sign a form agreeing to join the study).
  • You cannot have an active autoimmune disease (a condition where the immune system attacks the body’s own tissues).
  • You cannot have a diagnosis of non‑classical Hodgkin lymphoma or composite lymphoma (a mix of two different lymphomas).
  • Your ECOG performance status (a score that measures how well you can perform daily activities) must not be greater than 2.
  • You must not have received prior treatment for Hodgkin lymphoma, except for short courses of corticosteroids (steroid medicines).
  • Pregnancy or breastfeeding makes you ineligible to participate.
  • You cannot have another active cancer, or a cancer that was diagnosed less than 5 years ago after completing treatment.
  • Your diabetes must be well‑controlled; uncontrolled diabetes mellitus excludes you.
  • You cannot have heart failure that is worse than NYHA class II (a moderate level of heart failure) or a left ventricular ejection fraction (a measure of heart pumping ability) below 45%.
  • Your liver must function within limits: bilirubin (a substance processed by the liver) must not be more than 1.5 times the normal range, and AST/SGOT (a liver enzyme) must not be more than 5 times the normal range unless caused by lymphoma; you also cannot have Gilbert’s syndrome (a mild inherited liver condition).
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Investigated drugs

  • Nivolumab

    is an immunotherapy medicine that helps the body’s immune system spot and attack cancer cells. In this study it is given by IV infusion as part of the experimental N‑AVD treatment for advanced Hodgkin lymphoma.

  • Etoposide

    is a chemotherapy drug that interferes with the DNA of cancer cells, making it harder for them to grow. It is used in the standard BrECADD regimen to treat Hodgkin lymphoma.

  • Dexamethasone

    is a steroid taken by mouth that reduces inflammation and can lessen some side effects of chemotherapy. In the trial it is included in the comparator treatment plan.

  • Dexamethasone phosphate

    is the injectable form of the steroid dexamethasone. It works the same way to control inflammation and help manage chemotherapy‑related side effects in the comparator arm.

  • Doxorubicin

    (also known as Adriamycin) is a chemotherapy drug that kills cancer cells by damaging their DNA. It is a component of both the experimental N‑AVD regimen and the standard BrECADD regimen.

  • Vinblastine

    is a chemotherapy agent that stops cancer cells from dividing and spreading. It is included in the N‑AVD regimen.

What is already known about the treatment

  • Nivolumab

    This drug is given by intravenous infusion, usually over 30 minutes. It is an approved cancer medicine that works by blocking a protein called PD‑1, helping the body’s immune cells recognize and attack tumors. It is mainly used for treating various cancers, including Hodgkin lymphoma, and belongs to the class of immune checkpoint inhibitors. Clinical studies continue to explore its benefits and safety in new treatment combinations.

  • Etoposide

    Etoposide is administered by intravenous injection. It is a well‑established chemotherapy agent that interferes with the DNA‑copying process in cancer cells, leading to their death. It is used for several solid tumors and for Hodgkin lymphoma, and it is classified as a topoisomerase II inhibitor. It remains a standard part of many chemotherapy regimens.

  • Dexamethasone

    Dexamethasone is taken orally as a tablet. It is a synthetic steroid that reduces inflammation and suppresses the immune response, which can help control side effects of cancer treatment. It is widely used for many conditions, including as a supportive drug in cancer therapy, and belongs to the class of glucocorticoids. Its safety and effectiveness are well documented in medical literature.

  • Dexamethasone phosphate

    This form of dexamethasone is given by injection. It works the same way as oral dexamethasone, decreasing inflammation and immune activity, and is used to prevent allergic reactions and reduce chemotherapy‑related nausea. It is a glucocorticoid and is approved for many inflammatory and oncologic uses. The injectable version allows rapid action when needed.

  • Doxorubicin hydrochloride

    Doxorubicin is given as a solution for infusion into a vein. It is a long‑standing chemotherapy drug that inserts itself between DNA strands, stopping cancer cells from multiplying. It is used for many cancers, including Hodgkin lymphoma, and is classified as an anthracycline antibiotic. Decades of research have defined its benefits and possible heart‑related side effects.

  • Vinblastine sulfate

    Vinblastine is administered intravenously. It blocks the formation of microtubules, which are needed for cancer cells to divide, leading to cell death. It is approved for Hodgkin lymphoma and other cancers and belongs to the class of vinca alkaloids. Its use is supported by extensive clinical experience.

Investigated diseases

Hodgkin lymphoma - Hodgkin lymphoma is a cancer that begins in the cells of the lymphatic system, which helps protect the body from infection. It usually starts as a painless swelling in a lymph node, often in the neck, chest, or under the arms. Over time, the abnormal cells can spread to nearby lymph nodes and other organs such as the spleen, liver, or bone marrow. The disease may cause symptoms like fever, night sweats, and weight loss as it grows. Its progression is typically gradual, with the cancer expanding step by step through the lymphatic network.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2026-525263-41-00Protocol codePLRG-HL05Estimated enrolment370 patients

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